N/A(healthy adults)
Conditions
Interventions
Oral intake of the test product (containing mushroom mycelium powder
10 capsules / day for 4 weeks)
Sponsors
RCT Japan Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-69 years [2]Individuals who are sensitive to the cold [3]Individuals whose written informed consent has been obtained [4]Individuals who can come to the designated venue for this study and be inspected [5]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals who is patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis) [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [5]Individuals who is a patient or have a history of or endocrine disease [6]Individuals whose BMI is over 30 [7]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [8]Individuals with serious anemia [9]Individuals who are sensitive to a test product or other foods, and medical products [10]Individuals who are or are possibly, or are lactating [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period [13]Individuals who participated in other clinical studies in the past 3 months [14]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Existence and its contents of side effects(Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Adverse events (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [2]Blood pressure, pulsation (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [4]Body temperature (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [5]Hematologic test (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [6]Blood biochemical test (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [7]Urine analysis (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [8]Doctor's questions (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) *Other index [1]Subject's diary (each day during the test period) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Division of Clinical Trial, Department of Development for Clinical Trials
Outcome results
None listed